Many of those working within the medical communications industry will be familiar with the Good Publication Practice (GPP) guidelines, which were recently updated with the publication of GPP 2022. The guidelines provide recommendations on how to follow ethical and transparent practices when publishing company-sponsored biomedical research. GPP 2022 is the fourth version of the guidelines, which were previously updated in 2015 with the release of GPP3. The Publication Plan spoke to Lisa DeTora, Associate Professor at Hofstra University and lead author of GPP 2022, to find out how the guidelines were developed and to gain her insights on some of the new topics covered.
Could you explain why the time was right to update the guidelines and briefly summarise the key topics introduced in the new version?
“Although I was not part of the decision-making process that determined a new GPP iteration was needed, my understanding is that several new areas were identified that required some guidance—notably enhanced content and patient involvement in publications.
We concentrated on stating the goals of GPP in positive terms. Unlike the GPP3 team, who had to contend with negative coverage of publication planning in the press, we were able to define good practice without having to address negative accusations or practices. As such, GPP3 indirectly reflects on some media preoccupations with bad practices, including ghostwriting, and how to prevent them, whereas our team was able to concentrate on defining what we as a profession already do well and to present additional best practices that have emerged since 2015.
The scope of GPP 2022 expanded beyond clinical trial publications to cover all scientific areas. We moved away from mainly considering Consolidated Standards of Reporting Trials (CONSORT)-specific papers and acknowledge that the International Committee of Medical Journal Editors (ICMJE) authorship criteria are not universally used, even though they are an appropriate default if no other authorship guidelines are specified.
We broke down the various processes in publication planning in a supplement that walks the reader through steering committees, publication planning, authorship determination, publication working groups, and the publication process. In each of these areas, we included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries (PLS). These sections are intended to be usable for day-to-day work, for training teams, and for orienting newcomers to the profession.
“We included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries.”
We also added information about the leadership potential of publication professionals in developing policies and standard operating procedures (SOPs), and training teams.
Inclusivity was also an important new theme: we considered this in terms of demographic criteria, job roles, patients, and including investigators from various regions on author bylines.”
GPP 2022 was developed with input from pharma, medical communication agencies, journal editors, publishers, and academics, and underwent substantial review with over 150 invited expert and International Society for Medical Publication Professionals (ISMPP) member reviewers providing feedback. Could you briefly describe the development process?
“The original vision for this GPP iteration was to update GPP3 and then to add any new sections that might be needed. However, as the steering committee members began to develop the new content and updates, it became clear that we could produce a much more usable document. I was nominated to produce the full draft in part because I had some ideas about how I would organise what is now the supplement, and how those sections could be used for training and to introduce practices to investigators, students, and others. It was a little daunting because I had not envisioned being asked to take on a decision-making role for this work. Luckily, the steering committee was very supportive and positive.
In terms of the process, the steering committee began by identifying GPP3 content that required an update and new content that needed to be added. We reviewed all the content together, then I organised a new draft. The steering committee commented, and a consolidated document was then shared with a panel of 38 experts selected by the steering committee in consultation with ISMPP’s leadership. We consulted with ISMPP because we wanted to include expert reviewers who lead publications teams at pharmaceutical companies.
Fiona Plunkett (Articulate Science), Dan Bridges (Inizio Medical), and I then reviewed the 38 sets of expert comments. I consolidated the comments that we felt were feasible to include, then the steering committee commented, and the resulting document was sent for a review by ISMPP volunteers, who had been identified through an open call. Volunteer reviewers were asked to solicit feedback within their groups or companies and return consolidated comments via a portal set up by ISMPP. The steering committee members divided up the comments for preliminary review, but I read all of the comments and Dikran Toroser (Merck) read most of them as well, before I consolidated the document.
We accepted every comment that we could. I felt strongly that we needed to make sure stakeholders felt heard. As expected, though, some of the comments conflicted and then we deferred to the original steering committee views. The majority of the comments that we could not address were highly specific to a particular working setting or were editorial in nature. For instance, there were suggestions about minimum and maximum numbers of authors or steering committee members; the rationale for each of the suggestions was sound in a specific context but didn’t always apply in other scenarios. We also listened to feedback in person at the ISMPP Annual Meeting and in our day-to-day working relationships.
There was only one substantive difference of opinion regarding what to include in GPP 2022, and that was resolved by deferring to regulatory frameworks. In all other cases, we were able to develop text that would accommodate a range of acceptable approaches. For instance, we do recommend steering committees if teams need advice about scientific strategy or journal selection; however, it is not always feasible to have a separate steering committee and publication working group.”
How did you ensure that the guidelines represented balanced views and experiences of a diverse group of stakeholders, and that all voices were heard?
“We tried to keep GPP 2022 as neutral and high-level as possible, and to emphasise the idea that inclusivity should be considered in all areas of publication planning and development. The steering committee itself is diverse and we also solicited feedback from a diverse group of expert stakeholders. In addition, we accepted every comment that was feasible to address from the volunteer review.
One thing to keep in mind about listening to diverse voices is that a high-level document like GPP 2022 is not the correct place to establish what counts as diversity and inclusion in practice for every working setting. All we can do is to indicate that best practice in research and publication includes attention to diversity, equity, and inclusion at all stages. Attention also needs to be paid to inclusivity and diversity during study design, for instance, but that may be outside the remit of many publication teams. We can look to the ICMJE Recommendations for a model: they indicate that author lists should reflect representation from all regions (and countries, if feasible, I believe) in which a study was performed. I personally feel that we all need to keep thinking and continuously evaluate how we are doing in terms of diversity and inclusion and in listening to various stakeholders. We can employ “Lean” or Six Sigma practices that emphasise continuous evaluation, for instance.
Of course, there is more work to be done. It’s impossible in a high-level document like GPP 2022 to fully capture methods for building trust and working relationships with patients and patient advocate groups, or to account for regional representation in multiregional clinical trials or other kinds of studies. It’s also difficult to mandate how and when to include patients, given the wide range of study and publication types we consider. The best we could do for this initial mention of patient participation in GPP is to emphasise that patients should be included as appropriate—for instance in publications of clinical trial results in chronic conditions and/or rare diseases—and as equal partners. Patients should be treated as experts in living with conditions, whose expertise warrants respect, and authorship, if they contribute substantively to a publication. However, patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.
“Patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.”
Another sticky issue is including investigators from various regions on author bylines. There has been a past pattern of not including investigators from certain regions on the main author byline of a publication, but adding names for regional conferences. The current ICMJE Recommendations indicate that the main author byline should reflect all of the regions in which the research was conducted. GPP 2022 supports this position as well: if authorship reflects the full breadth and scope of participation in multiregional clinical trials, then there is no need to manage additions for conferences.”
The guidelines note that patients and patient advocates may author publications or be involved in publication planning. What do you think are the key benefits of patient involvement?
“In my opinion, the key benefit of patient involvement in publications about rare or chronic conditions is that only patients really understand the lived experience of having those conditions. Patients are the only true experts regarding these experiences and are the only group of people who can contextualise scientific outcomes in terms of patient experience. Understanding patient experiences is also vital for anticipating compliance issues, untoward outcomes, or even what kinds of outcome measures could be used to assess certain kinds of adverse effects. Patient input is essential for fully understanding patient reported outcomes, not only in terms of interpretation but also for designing the measures in the first place.
In clinical study settings for acute illnesses or vaccines, patient or participant involvement may still be important and should be strongly considered. It may not be necessary to have a patient on every publication, but patient steering committees may offer important advice to publications teams, review manuscripts, and provide guidance on the best way to represent study findings in plain language. As I said earlier, GPP can’t mandate the exact practice for every situation; however, there should be some mechanism to solicit patient or participant input on relevant publications, even if the patients and participants opt not to engage with the publication process.
Another important benefit to patient involvement in publications is holding the biomedical research community accountable for communicating their findings clearly, accurately, and completely. It is all too easy for researchers to become used to interacting only with other experts, and rely on readers to fill in the blanks of logic or data interpretation. The need to communicate with patients can help experts keep in mind that many different groups of people rely on their research, and to be thorough and complete in presenting analysis and interpretation of results.”
Were any challenges or obstacles identified that may need to be overcome for patients to more frequently author publications?
“In my view there is a difference between including patient voices in the publication process and trying to expand patient authorship of publications. I really think that patients need to be making the decisions about how they would like to be involved in the publication process and whether they would like to expand their presence as authors. For instance, we need to think about the burdens of authorship—which can be difficult and time consuming—and what it’s fair to ask patients to do. We also need to consider what patients want to do. There are potential questions of medical confidentiality to consider, for instance. However, these are my opinions, and the opinions that are truly needed are those of patients who might want to author or provide different kinds of feedback on publications. We should also consider the value of patients as peer reviewers of publications and PLS.
In terms of GPP 2022, we did not delve deeply into these questions because we took the stance that patients should be included as equal stakeholders at all stages of the publication process, where appropriate, which leaves the decision-making to those specific teams and those patients. In general, I believe that it is important that patients take the lead in setting the terms of these discussions. The most important thing to remember, again in my opinion, is that if patients are involved, they should be treated as co-equal partners with investigators and other publication stakeholders.”
GPP 2022 endorses the inclusion of enhanced content with publications, including PLS. Could you explain why PLS are considered so important and briefly outline the key recommendations on when and how they should be developed?
“Enhanced content utilises different forms of media, often visual media, to make publications more accessible to various expert and nonexpert audiences. For instance, supplemental tables might be included to allow meta-analytical work, or a 1-minute video could explain the key points of a clinical study to help researchers decide whether or not to read a paper in detail. In paediatric trial settings, enhanced content in comic book or infographic form can also be really useful for conveying information. Such visual formats can also be beneficial in settings where literacy is an issue, or if there is a need to communicate with speakers of minoritised languages.
GPP 2022 recommends that a PLS accompany every publication of clinical trial data that follows the CONSORT guidance—which basically means every primary publication. Of course, a PLS might be helpful for every publication, but it is especially critical to communicate clearly about clinical trials of products currently being used in medical practice.
“For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is.”
For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is. It can be easy to fall into ‘expert speak’ and assume that all readers will be able to navigate technical jargon and fill in any gaps in logic. However, PLS have many audiences, from patients to medical students to experts or healthcare professionals who speak English as a foreign language. The PLS format requires a clearer statement of the work’s importance.
There are many ways (and times) to develop a PLS. The simplest PLS is an abstract form that restates the study design and outcomes in plain language. Developing infographics or comics or video can be more expensive and time-consuming. Teams should consider carefully which audiences they are serving and how important it is to convey which information to those audiences. One recommendation I have is to look at recent statements on PLS by publishers and editors. Journal requirements will help guide teams regarding the time needed to develop a PLS to accompany a publication.”
The importance of inclusivity is highlighted in GPP 2022. Could you describe the aspects of inclusivity considered by the guidelines and share some examples of how those working within medical communications might be able to encourage inclusivity in publications?
“GPP 2022 recommends inclusivity of many sorts—from demographic characteristics to job roles, to countries and regions, to patients. One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.
“One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.”
This includes diversity in terms of race, ethnicity, and gender as well as scientific roles. Treating patients as co-equal partners is another form of inclusivity we recommend, as is including investigators from various regions on author bylines. Obviously, the best place to start thinking about inclusivity is at study design stage—but publication professionals should still consult with subject matter experts and data owners to identify diverse teams even if they enter the picture after study design is established.
In general, it’s easy to try to be inclusive but difficult to adjust team culture to accommodate differences and be truly equitable. For instance, including regional investigators may require adjusting timelines and being tolerant of multi-language working situations. I’ve worked on teams where we accepted comments in all languages spoken by the co-authors and then produced the drafts in English. It’s also important to recognise that in some cultures, opinions must be requested more than once. It may also be necessary to adjust meeting times to include partners around the globe. Patients and investigators are also people who have jobs and other responsibilities, which may mean that timelines need some adjustment in order to be truly inclusive.”
The development of GPP 2022 took place during the COVID-19 pandemic. Did any challenges faced by the medical publications community during this time, or changes such as the rise in popularity of preprints, impact any of the recommendations?
“We were somewhat delayed from our initial timeline because many people working within the industry became a lot busier. And those, like me, in academic roles had a lot of added logistical pressures. I asked to include a statement about publication ethics during public health emergencies in GPP 2022, which was received as rather non-controversial by the rest of the authors, given the circumstances. We did have some discussion of preprints, but it was actually quite easy to come to a consensus about our recommendation because we were well aligned around the idea that preprints have a specific function, but should not be used to circumvent the peer review process.”
Were there any topics included in GPP 2022 that proved particularly controversial or difficult to reach consensus on?
“We were quite well aligned at a high level on almost every issue. The logistics or granular details at times are not entirely aligned, but that is a circumstance out of any individual person’s control. It is a strength of the group, in fact, that we are not all working in precisely the same way.
The one thing I’m comfortable saying about any ‘lively debate’ among the team members was that it always seemed to arise out of what turned out to be authentic legal and regulatory differences. In other words, we did not really disagree ultimately, but we were coming together from different positions and/or working within different frameworks. For instance, social media posting doesn’t fall under ‘safe harbour’ protections for industry partners, and caution is warranted when developing a standalone PLS if any information is off-label. This meant that certain ‘common sense’ approaches would not work in all situations. We therefore recommend evaluation of legal and regulatory requirements on an ongoing basis, as well as consulting with legal and other experts.
Another interesting conversation was how to manage situations in which legal or other constraints were not the same for all stakeholders. For instance, compensating investigators to be on a steering committee might be a legally reportable transfer of value, which would not be the case for patients who are not healthcare providers. Similarly, social media posting about publications can have very different implications depending on who is posting and the relationship of the publication to label indications or accepted treatment guidelines. We tried to offer advice that took all of these considerations into account, but individual publications professionals will still have to manage day-to-day situations.”
How have the guidelines been received so far? Have you received any initial feedback as to how they will be incorporated and used?
“My impression is that they’re being adopted as feasible. There are some changes, and many publication teams still work primarily with clinical trial publications, which means that some of the new information does not apply. We received 0% negative feedback during the reviews, which was very gratifying after putting in so many hours.
A few people have been fairly clear in wanting very specific guidance to be included. One instance is specific limits on the number of steering committee members or authors: these make sense in certain situations but not others. My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”
“My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”
Would you like to see greater involvement of any stakeholders, such as patients, in the development of future GPP guidelines?
“My personal feeling is that we really need a patient-led document on publications that outlines what patients would like to see, similar to the article written by Hesp et al on applying GPP3 in the Asia–Pacific region, taking GPP3 principles and translating them to the regional context.
It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.
“It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.”
I’d also like to see what experts in various scientific and medical specialties might recommend to their members.”
What do you predict is next for GPP? Which topics may need to be covered in future iterations of the guidelines as the publications landscape evolves?
“I sincerely hope this iteration lasts for several years. The next steps I foresee are answering any FAQs and identifying areas that need attention. For instance, there seems to be some question about how many steering committees to have. GPP 2022 covers several possibilities and I think day-to-day experts, of whom there are many, should share their experiences. As a next step, I also see various groups commenting on how they apply GPP principles in various working contexts. It would be especially helpful, for instance, to hear more from people working in low- and middle-income countries about the needs for training or support to enable inclusion in steering committees and authoring teams. As noted, I also believe that we need to hear more from patients—there are some publications on how to form a patient steering committee, for instance, but there seems to be a space for more work, such as how to help patients participate in peer review.
We anticipated that artificial intelligence and other technological advances will impact publications and that journals will enhance their policies on preprints. These should not affect the main principles of GPP, though, I would hope.”